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TECHNESCAN HDP - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - TECHNESCAN HDP

What TechneScan®HDP is and what it is

This medicine is a radiopharmaceutical product for diagnostic use only.

TechneScan HDP is used through a scan to examine the:

  • bones

The use of Technescan HDP does involve exposure to small amounts of radioactivity. Your doctor and the Nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweights the risk due to radiation.

This medicine is a powder. When mixed by qualified people, with a solution of the radioactive substance, sodium pertechnetate (99mTc) it forms Technetium (99mTc) oxidronate. When administered into the body it collects in certain organs such as the bones.

The radioactive substance can be photographed from outside the body, using special cameras which take a scan. This scan shows the distribution of radioactivity within the body. This gives the doctor valuable information about the structure and function of a specific part of the body.

W

Do not use TechneScan® HDP

  • if you are allergic (hypersensitive) to sodium oxidronate or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Take special care with Technescan HDP

  • if you are pregnant or believe you may be pregnant.
  • if you are breast-feeding.

Before Technescan HDP administration you should:

drink plenty of water before the start of the administration in order to urinate as often as possible during the first hours after the study

Children and adolescents

Please speak to your Nuclear medicine doctor if you are under 18 years old.

Using other medicines

Please tell your Nuclear medicine doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription since they may interfere with the interpretation of the images.

The following medicines can influence or be influenced by Technescan HDP :

  • medicines to treat reduced bone density with active substance names ending with „dronate“
  • tetracycline: an antibiotic
  • iron based medicines
  • aluminium based stomach acid binding medicines
  • medicines to treat heavy metal poisoning

Pregnancy, breast-feeding and fertility

You must inform the Nuclear medicine doctor before the administration of Technescan HDP if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.

When in doubt, it is important to consult your Nuclear medicine doctor who will supervise the procedure.

If you are pregnant

The Nuclear medicine doctor will only administer Technescan HDP during pregnancy if a benefit is expected which would outweigh the risks.

If you are breast-feeding

Tell your doctor if you are breast-feeding as he may delay treatment until breast-feeding is finished. He may also ask you to stop breast-feeding and discard this milk, until the radioactivity is no longer in your body. Please ask your Nuclear medicine doctor when you can resume breast-feeding.

Driving and using machines

It is considered unlikely that Technescan HDP will affect your ability to drive or to use machines.

Important information about some of the ingredients of Technescan HDP

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.

3.

There are strict laws on the use, handling and disposal of radiopharmaceutical products. Technescan HDP will only be used in special controlled areas. This product will only be handled and given to you by people who are trained and qualified to use it safely. These persons will take special care for the safe use of this product and will keep you informed of their actions.

The Nuclear medicine doctor supervising the procedure will decide on the quantity of Technescan HDP to be used in your case. It will be the smallest quantity necessary to get the desired information.

The quantity to be administered usually recommended for an adult ranges from 300 to 740 MBq (Mega Becquerel, the unit used to express radioactivity).

Use in children and adolescents

In children and adolescents, the quantity to be administered will be adapted to the child’s weight.

Administration of Technescan HDP and conduct of the procedure Technescan HDP is administered by injection.

One injection is usually sufficient to conduct the test that your doctor needs. Dependent upon the information required, scans are made immediately or no sooner than 2 hours after the injection.

After injection, you will be asked to drink and urinate as much as possible in order to prevent active substance gathering in the bladder.

Duration of the procedure

Your Nuclear medicine doctor will inform you about the usual duration of the procedure.

After administration of Technescan HDP, you should: urinate frequently in order to eliminate the product from your body.

If you have been administered more Technescan HDP than you should An overdose is almost impossible because you will only receive a single dose of Technescan HDP precisely controlled by the Nuclear medicine doctor supervising the procedure. However, in the case of an overdose you will receive appropriate treatment.

Drinking as much as possible, such as water, will help remove the radioactive substance more quickly.

Should you have any further question on the use of Technescan HDP, please ask the Nuclear medicine doctor who supervises the procedure.

4.

Like all medicines, Technescan HDP can cause side effects, although not everybody gets them.

This radiopharmaceutical will deliver low amounts of ionising radiation with very low risk of cancer and hereditary abnormalities.

Side effects can occur with the following frequencies: frequency unknown , from the data available

  • serious allergic reactions may occur with symptoms such as:

  • – life-threatening allergic shock reaction, loss of consciousness

  • – heart and respiratory arrest, breathing difficulties

  • – mostly painful severe swelling of deep skin layers, mainly in the face

  • – increased heart beat, high blood pressure

  • – inflammation inside the nose or of the outermost layer of the eye – skin inflammation, reddening, rash, itching, increased sweating

  • – swellings of different types caused by excess fluid

  • – taste disturbance, sensation disorder such as pricking, burning Hospital staff will treat these allergic reactions immediately, if they occur.

  • severe reactions caused by the nervous system with symptoms such as

  • – fainting fit, circulatory collapse

  • – dizziness, headache

  • – increased or reduced heart beat, low blood pressure

  • – shakiness, blurred vision, flushing

  • vomiting, nausea
  • diarrhoea
  • stomach pain
  • injection site reactions such as inflammation, pain, skin reddening, swelling
  • chest pain
  • chills

If you get any side effects talk to your Nuclear medicine doctor. This includes any possible side effects not listed in this leaflet.

5.

You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Storage of radiopharmace­uticals will be in accordance with national regulation on radioactive materials.

The information is intended for the specialist only.

Technescan HDP will not be used after the expiry date stated on the label.

Technescan HDP will not be used if visible sign of deterioration are noticed.

6.


Contents of the pack and other information

What TechneScan HDP contains

  • The active substance is sodium oxidronate.
  • The other ingredients are: gentisic acid, hydrochloric acid, sodium chloride, sodium hydroxide, stannous chloride dihydrate

What TechneScan HDP looks like and contents of the pack

Technescan HDP is a grey-white lyophilized powder. It is packaged in 10 ml colourless glass vials closed with a bromobutyl rubber stopper and sealed with an aluminium crimp cap with a blue flip-cap.

Pack size

Technescan HDP is supplied in a carton box that contains 5 vials.

Marketing Authorisation Holder and Manufacturer

  • Marketing Authorisation Holder

Curium Netherlands B.V., Westerduinweg 3

1755 LE Petten, The Netherlands

PL 12288/0012

  • Manufacturer

Curium Netherlands B.V., Westerduinweg 3

1755 LE Petten, The Netherlands

This leaflet was last approved in 05/2019

32-APP-4366-United-Kingdom-PIL-15052019_clean.doc

2

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is TECHNESCAN HDP used for?

TECHNESCAN HDP is a radiopharmaceutical used in medical imaging. It helps doctors visualize certain organs and systems in your body, mainly for assessing bone health or detecting diseases.

How does TECHNESCAN HDP work?

TECHNESCAN HDP contains a radioactive substance that emits gamma rays, which can be detected by special cameras during imaging tests, allowing doctors to see how well your bones are functioning.

Is TECHNESCAN HDP safe for everyone?

While TECHNESCAN HDP is generally safe, it may not be suitable for pregnant women or those with allergies to its components. Always discuss your medical history with your doctor before use.

What should I inform my doctor about before taking TECHNESCAN HDP?

Inform your doctor about any medications you are taking, any allergies you have, especially to iodine or radiopharmaceuticals, and if you are pregnant or breastfeeding.

How is TECHNESCAN HDP administered?

TECHNESCAN HDP is usually injected into a vein by a trained healthcare professional in a clinical setting.

What should I expect during the TECHNESCAN HDP procedure?

During the procedure, you'll receive the injection and then wait for a period (usually a few hours) before the imaging scan is performed to allow the substance to distribute in your body.

Are there any side effects of TECHNESCAN HDP?

Common side effects may include mild pain or swelling at the injection site. Serious side effects are rare but can occur; report any unusual symptoms to your doctor immediately.

Can I eat or drink before my TECHNESCAN HDP scan?

You may be advised to avoid food and drink for several hours before the scan; follow your doctor's instructions on preparation.

How long do I need to wait for the scan after receiving TECHNESCAN HDP?

Typically, you will wait 2-4 hours after receiving the injection before undergoing the imaging scan.

How long does a TECHNESCAN HDP scan take?

The imaging scan itself usually takes about 30 minutes to an hour, depending on what is being assessed.

Will I feel anything during the TECHNESCAN HDP injection?

You may feel a slight pinch or sting when the needle is inserted, but it typically lasts only a moment.

Can I go back to my regular activities after receiving TECHNESCAN HDP?

In most cases, you can resume normal activities right after the procedure unless advised otherwise by your healthcare provider.

What happens after my TECHNESCAN HDP scan?

After your scan, your results will be analyzed by a specialist and discussed with you at follow-up appointments. You may not receive results immediately.

Are there any special instructions after receiving TECHNESCAN HDP?

Your doctor may provide specific instructions post-procedure; generally, it's important to stay hydrated and avoid close contact with pregnant women and infants for a short time after administration.

Can TECHNESCAN HDP affect my kidney function?

In most patients with normal kidney function, TECHNESCAN HDP does not negatively affect kidney health. However, if you have kidney problems, discuss this with your doctor beforehand.

Is there an alternative to using TECHNESCAN HDP for bone imaging?

Yes, alternatives such as CT scans or MRIs may be available depending on what needs to be assessed. Discuss options with your healthcare provider.

Why is radiation used in medical imaging like TECHNESCAN HDP?

Radiation helps produce clearer images of internal body structures that are difficult to see otherwise, aiding in accurate diagnosis and treatment planning.

How often can I have a scan using TECHNESCAN HDP?

The frequency of scans using TECHNESCAN HDP depends on individual health needs. Your doctor will determine the appropriate interval based on your condition.

Will insurance cover my test with TECHNESCAN HDP?

Most insurance plans provide coverage for medically necessary imaging tests like those using TECHNESCAN HDP. Check with your insurer for specifics related to coverage and copays.

Where can I get a TEST using TECHNESCAN HDP done?

TECHNESCAN HDP scans are performed in specialized nuclear medicine clinics or hospitals; consult your healthcare provider for recommendations based on location.